Multiple layer filamenyary devices for treatment of vascular defects

ABSTRACT

Braid-balls suitable for aneurysm occlusion and/or parent vessel occlusion/sacrifice (e.g., in treating neurovascular defects) are disclosed. Especially for aneurysm treatment, but also for either one of the aforementioned treatments, the form of the ball is very important. In particular, the density of the device is paramount in applications where braid itself is intended to moderate or stop blood flow—allowing thrombosis within a volume formed by the ball.

CROSS REFERENCE TO RELATED APPLICATIONS

This filing is a continuation of U.S. patent application Ser. No.12/911,034, filed Oct. 25, 2010, which is a continuation of U.S. patentapplication Ser. No. 12/427,620 filed Apr. 21, 2009 which claims thebenefit of each of: U.S. Patent Application Ser. Nos. 61/046,594 and61/046,670, both filed Apr. 21, 2008; U.S. Patent Application Ser. Nos.61/083,957 and 61/083,961, both filed Jul. 28, 2008; and U.S. PatentApplication Ser. No. 61/145,097, filed Jan. 15, 2009. Each of theforegoing applications is incorporated herein by reference in itsentirety.

FIELD OF THE INVENTION

The present invention is directed to braid-balls suitable for aneurysmocclusion and/or parent vessel occlusion/sacrifice (e.g., in treatingneurovascular defects).

BACKGROUND

Especially for aneurysm treatment, but also for either one of theaforementioned treatments, the form of the ball is very important. Inparticular, the density of the device is paramount in applications wherebraid itself is intended to moderate or stop blood flow—allowingthrombosis within a volume formed by the ball.

According to the present invention, braid-ball type implants areprovided in braid of sufficient density is provided to moderate bloodflow within the volume of the implant. Upon thrombosis, flow thereto isstopped. Alternatively, a blood-barrier covering can be applied to thefilamentary structure to immediately stop blood flow into the vascularsite, in which the implant volume is set.

In either case, to form thrombosis within the volume of the ball, thefilaments of the braid matrix permit filling of the implant with bloodwhen emplaced at a vascular treatment site. This blood then thrombosesdue to the flow-disruption effect(s).

Unlike Nitinol tube-cut cages that may be suitable for (or assist) incoil retention, the ball devices are adapted to work alone—or incombination with each other to effect a complete treatment. As such,high density braid/mesh is typically required. Namely, braid having atleast about 48 ends, typically set at about 90 degrees or greater, indiameters from about 4 to about 8 mm may be employed. At largerdiameters (e.g., about 6 to 12 or more), more wire ends (e.g., 64, 72and upwards) may be employed in forming the balls.

Suitable braid for constructing the balls may be obtained from SecantMedical, Inc. Wire diameters may be in the range of about 0.001 to about0.003 inches, depending on desired delivery profile (which is typicallyless than about 0.050 inches). The braid forming the balls mayincorporate only one size wire, or may be formed with multiple sizes.

The wire is preferably superelastic NiTi alloy. The metal may be abinary alloy or a ternary alloy to provide additional radiopacity.Alternatively, radiopaque platinum fibers may be included in the braid,or the wire may comprise platinum or gold cord Nitinol DFT. Otherwise,wraps or bands (preferably Pt) used to secure the braid wire may serveas the sole radiopaque feature(s).

In any case, the construction approaches described herein enableproducing these useful devices. Whether comprising braid alone, orincorporating some further blood-barrier covering (such as a thinurethane film as may be applied by Hantel, Inc. or others) the use ofbraid presents numerous challenges in managing the termination ofmultiple wires and in forming the desired structures.

Also included in the invention are detachable implant pushers thatutilize a resistance wire heater to thermally sever a suture associatedwith the implant to effect release. As distinguished from knownapproaches where an implant is retained by a loop connected back to adelivery system pusher that is withdrawn with the devilry system, thepresent invention contemplates a leave-behind tether.

Further details, variations, modification and optional features of theinvention may be appreciated by review of any of the incorporated patentapplications. However, the priority date and subject matter included inthe appended claims rely solely on the subject matter filed in U.S.Provisional Patent Application Nos. 61/046670 and 61/046594, theearliest patent applications (each filed Apr. 21, 2008) one which U.S.patent application Ser. No. 12/427,620 relies. Selected figures from the'670 and '594 application and all of text from the '594application—all—incorporated by reference in the parent applicationhereto is reproduced herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a photograph taken from U.S. Provisional Patent Appl. No.61/046,670 (incorporated herein by reference) demonstrating actualreduction to practice of a single-layer braid ball device made accordingto the present invention;

FIGS. 2A and 2B are side-sectional views of the braid ball in isolationand in use, respectively;

FIG. 3 illustrates a suture-melt resistance heater pusher for implantdelivery; and

FIGS. 4A-4F illustrate a production path of one implant embodimentencompassed by the current invention.

DETAILED DESCRIPTION OF THE INVENTION

Implants

Referring to the figures, a filamentary implant 2 is formed out of braidto treat vascular sites. Interwoven filaments 4 form a braid matrix 6that define a self-expandable occlusion device.

As single layer of the braid is provided in which ends of the braid aresecured and managed to provide an atraumatic interface. Specifically,ties 10 (as illustrated in FIG. 1) or bands 12 (as illustrated in FIG.2A and 2B) secure filament the ends 14 of the braid from which theimplant is constructed.

In the implant variation pictured, the expanded configuration defines anovoid or roughly spherical shell 18 that is permeable to blood. Thebraid defining the proximal and distal ends of the implant turns orcurves inward to a point where it is secured within the periphery of theshell.

The inversion of the braid provides recessed securement of the braidresulting in atraumatic ends of the implant. The braid filamentsoptionally extend beyond the securing/securement features in order todefine wire filament “tufts” 20 that will further promote thrombosis ofblood that enters the ball upon deployment within a patient'svasculature. However configured in regard to braid filament endsecurement and termination, inset ends of the braid (proximal and distalinsets 22/24, respectively) are demonstrated when the implant is in anexpanded state to fill an aneurysm 26 off of a vessel 28.

Delivery Systems

FIG. 3 illustrates a detachable catheter/pusher 30, optionally, for usein the present invention. Generally, it includes a resistance wirebridge 32 across insulated conductors 34 (a typical construction). Whatis unique is that the conductor wires are twinned/twisted along a lengthof the delivery pusher shaft 38 as shown. This configuration alleviatesbending bias/preference. Upon application of voltage, the tip thermallysevers the polymer filament (e.g., suture 40) in contact therewith. Atleast the suture portion is received within the implant 2 (e.g., passingthrough a braid-securing band 12). The suture is retained in/with theimplant upon actuation to release the implant by cutting through thesuture with heat. A ball stop 42 that is tied to the suture retains thefilament in/with the implant is also illustrated. Finally, pusher 30 isshown received within a typical microcatheter 44 for vascular access,after passage therethough. Note also, other advantageous delivery systemare referenced and described in the incorporated patent application.

Methods of Manufacture

Included in the intention is a method of manufacture including tying-offor otherwise securing a second end of a braid within an interior volumeof a ball where other approaches would be impracticable. The techniquemay be employed in creating the balls (be they spherical or ovaloid incross-section, etc.) out of one continuous section of braid. In sodoing, joints and other delivery profile-increasing features areavoided—as well as potential areas for failure. Accordingly, the subjectimplants are extremely robust and fully recoverable to their aneurysmalshape as is required when they are delivered through a catheter in lowprofile. Robust shape recovery is required in treatments targetingdistal vasculature, especially the tortuous neurovasculature encounteredin human brains.

A detailed example of one process path for implant formation isillustrated in FIGS. 4A-4F. As shown in FIG. 4F an final implant 2 maybegin as a section 50 of braided material. The tubular braid stock issecured. As shown, it is tied-off with a wire wrap 10. Such actiondevelops an inset region 24 for the implant body. An opposite end of thebraid is then captured in a transfer tube 52. The tube is passed throughthe volume of the implant and secured with a second tie 10 at the otherside.

Additional refinement to the shape over that shown in FIG. 4E may beimparted within a shape-setting form 54. Mandrels 56 including stops 58received through the securement features may be employed to forceapposition of the ball to the shape of the form when pulled apart asindicated by arrows. After shape-setting in the form (as appropriate tothe selected material—e.g., as in heat setting superelastic Nitinol) themandrels are removed and the implant shaping is complete as shown inFIG. 4F. However, these additional forming steps are not necessary giventhat (in point of fact) the implant in FIG. 1 was produced withoutemploying the same.

Methods of Use

Any one of the subject implants is delivered to a target site employingknown percutaneous catheter access techniques. The implant may besecured to a pusher (e.g., pusher 30) used to advance it through theaccess catheter (e.g., microcatheter 44). Upon emplacement at thetreatment site (e.g., cerebral aneurysm 26 as illustrated in FIG. 2A),the implant can be detached. With the exemplary system shown in FIG. 3,the suture 40 passing through the proximal end of the implant 2 issevered by melting it using a resistance heater. This retention/releasefiber remains in and with the implant.

1-79. (canceled)
 80. An embolic device comprising: a braid forming innerand outer layers and configured to compress for delivery through acatheter and expand upon release from the constraint of the catheter todefine an open volume, wherein the inner and outer layers meet at afolded section that is closed to define a distal end of the device, andwherein the inner and outer layers further meet at a hub that closes andholds at least the outer braid layer at the proximal end of the device.81. The device of claim 80 wherein portions of the device adjacent tothe hub and to the folded section are rounded when fully expanded. 82.The device of claim 80 wherein the braid has a flared profile whenexpanded.
 83. The device of claim 80 wherein the braid is ball-shapedwhen expanded.
 84. The device of claim 80 wherein the inner and outerlayers at the folded section together define a dome-shaped atraumaticsurface when expanded.
 85. The device of claim 80 wherein the innerbraid layer is not held in the hub.
 86. The device of claim 80 whereinboth the inner and outer braid layers are held in the hub.
 87. Thedevice of claim 80 wherein the hub comprises an outer band and an innerband, wherein the braid is between the outer band and the inner band andthe inner band defines a hub port configured to receive an elongateddelivery member.
 88. The device of claim 80 wherein the hub isradiopaque.
 89. The device of claim 80 wherein the braid is one of a64-wire braid, a 72-wire braid, a 96-wire braid, a 128-wire braid, or a144-wire braid.
 90. The device of claim 80 wherein the braid comprises aplurality of wires, and wherein at least some of the wires are platinumcore Nitinol DFT or gold core Nitinol DFT.
 91. The device of claim 80wherein the braid comprises a plurality of wires, and wherein at leastsome of the wires are a superelastic alloy.
 92. An embolic devicecomprising: a mesh formed of an inverted tubular braid that has beenheat set to form a predetermined, three-dimensional shape in an expandedconfiguration, the braid comprising a plurality of wires having firstand second ends, wherein a distal end of the mesh has a folded sectionand defines a dome-shaped atraumatic surface when the mesh is expanded,and wherein the first and second ends of the braid are held together bya hub at a proximal end of the device.
 93. The device of claim 92wherein the three-dimensional shape is generally spherical.
 94. Thedevice of claim 92 wherein the hub comprises an outer band and an innerband, wherein the braid is between the outer band and the inner band andthe inner band defines a hub port configured to receive an elongateddelivery member.
 95. The device of claim 92 wherein the hub isradiopaque.
 96. The device of claim 92 wherein the braid is one of a64-wire braid, a 72-wire braid, a 96-wire braid, a 128-wire braid, or a144-wire braid.
 97. The device of claim 92 wherein at least some of thewires of the braid are platinum core Nitinol DFT or gold core NitinolDFT.
 98. The device of claim 92 wherein at least some of the wires ofthe braid are a superelastic alloy.
 99. The device of claim 92 whereinthe mesh includes an inner braid layer and an outer braid layer, andwherein the inner braid layer and the outer braid layer are continuousat the folded section.